# K201619: EndoTool IV System

- Pathway: 510(k) (Traditional)
- Applicant: Monarch Medical Technologies, LLC
- Decided: Aug 7, 2020 after 53 days
- Product code: NDC (Calculator, Drug Dose)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K941811 (1994). 37 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 40 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200443: EndoTool IV 1.10, Monarch Medical Technologies, LLC (2020) Summary page 4.

## Most influential descendants
- K241088: EndoTool IV (3.1) (2024), 1 descendant of its own
- K260910: EndoTool IV Cloud 1.0 (2026), 0 descendants of its own

## Indications for use
EndoTool IV is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool IV logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.

Source page: https://510kreport.com/device/K201619
Methodology: https://510kreport.com/methodology